Table XV

Extracted Elemental Impurities Reported for Multi-material Systems

Element	Test Article	Extraction Details		Extracted Concentration	Ref.
		Solvent	Conditions	Extracted Concentration	Ref.
Al	Capsule filter; PVDF membrane, PP shell	Water	Dynamic extraction with recirculation, ambient temperature, 24 h	6 ng/mL	18
	Capsule filter; PVDF membrane, PP shell	Ethanol		<0.1 ng/mL
	Plastic prefilled syringe	Placebo	50 °C, 1 week; 0.8% Polysorbate 80, 0.9% NaCl, pH 4	24 mg/kg	24
	Single-use manufacturing system	Simulant	5/10/90 [dimethylformamide (DMF)/ethanol/water], ambient, 7 days, agitation	<2 mg	36
	Syringe used to compound total parenteral nutrition solutions	Water	Static extract, filled syringe, 24 h at ambient temperature	1–10 μg/L	50
	Type 1 vials + halobutyl rubber closure	5% human serum albumin	60 °C for 10 h, followed by 1 month at 20 °C	100 μg/L	52
Ca	Capsule filter; PVDF membrane, PP shell	Water	Dynamic extraction with recirculation, ambient temperature, 24 h	22 ng/mL	18
	Capsule filter; PVDF membrane, PP shell	Ethanol		22 ng/mL	18
	Single-use manufacturing system	Simulant	5/10/90 (DMF/ethanol/water), ambient, 7 days, agitation	<2 mg	36
Cu	Capsule filter; PVDF membrane, PP shell	Water	Dynamic extraction with recirculation, ambient temperature, 24 h	2 ng/mL	18
Cu	Capsule filter; PVDF membrane, PP shell	Ethanol		<0.1 ng/mL
Mg	Capsule filter; PVDF membrane, PP shell	Water		3 ng/mL
Mg	Capsule filter; PVDF membrane, PP shell	Ethanol		<0.1 ng/mL
Na	Capsule filter; PVDF membrane, PP shell	Water		280 ng/mL
	Capsule filter; PVDF membrane, PP shell	Ethanol		160 ng/mL
	Single-use manufacturing system	Simulant	5/10/90 (DMF/ethanol/water), ambient, 7 days, agitation	<2 mg	36
Zn	Capsule filter; PVDF membrane, PP shell	Water	Dynamic extraction with recirculation, ambient temperature, 24 h	<0.1 ng/mL	18
Zn	Capsule filter; PVDF membrane, PP shell	Ethanol		2.2 ng/mL	18